Persona TM Tibia Clinical Outcomes Study

NCT ID: NCT03589300

Last Updated: 2024-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-30
• Study Completion Date: 2022-11-30

Brief Summary

The primary objective of this study is to evaluate clinical performance for the commercially available Persona TM Tibia used in primary cementless tibia total knee arthroplasty.

Detailed Description

This is a prospective, multicenter, non-randomized clinical study designed to facilitate the collection and evaluation of radiographic parameters, pain and function, survival of the device,and adverse event data.

The study will require each site to obtain IRB approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process.

All study subjects will undergo preoperative clinical evaluations prior to their cementless tibia total knee arthroplasty. An immediate postoperative radiograph will be required. Postoperative clinical follow-up and radiographic evaluations will be conducted at 6 weeks, 6 months, 1 year, and 2 years.

The primary endpoint of this study is to evaluate the clinical performance of the implant at 2 years postoperatively using radiographic parameters. Radiographs will be assessed for the absence of progressive tibial radiolucencies, as defined in the radiographic protocol.

The secondary endpoints of this study will evaluate the clinical performance of the implant at 2 years postoperatively, based upon:

• No revisions for any reason
• Oxford Knee Score >38

Conditions

Osteoarthritis; Rheumatoid Arthritis; Traumatic Arthritis; Polyarthritis; Collagen Disorders and/or Avascular Necrosis of the Femoral Condyle; Post-traumatic Loss of Joint Configuration; Moderate Valgus, Varus, or Flexion Deformities

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Persona TM Tibia subjects

Subjects that receive the Persona TM Tibia implant

Group Type: OTHER

Persona TM Tibia

Intervention Type: DEVICE

Trabecular Metal tibia used in primary cementless total knee arthroplasty

Interventions

Persona TM Tibia

Trabecular Metal tibia used in primary cementless total knee arthroplasty

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patient is at least 18 years of age.

2. Patient qualifies for a primary cementless tibia total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following:

1. Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.

2. Collagen disorders and/or avascular necrosis of the femoral condyle.

3. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.

4. Moderate valgus, varus, or flexion deformities.

5. The salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee.

3. Patient has participated in the study-related Informed Consent process.

4. Patient is willing and able to provide written Informed Consent by signing and dating the IRB approved Informed Consent Form.

5. Patient is willing and able to complete scheduled study procedures and follow-up evaluations as described in the Informed Consent Form.

6. Independent of study participation, patient is a candidate for commercially available cementless Persona TM tibial knee component, implanted in accordance with product labeling.

Exclusion Criteria

1. Previous history of infection in the affected joint.

2. Active local or systemic infection that may affect the prosthetic joint.

3. Insufficient bone stock on femoral or tibial surfaces.

4. Skeletal immaturity.

5. Neuropathic arthropathy.

6. Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb.

7. A stable, painless arthrodesis in a satisfactory functional position.

8. Severe instability secondary to the absence of collateral ligament integrity.

9. Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin.

10. Patient has previously received partial or total knee arthroplasty for the ipsilateral knee.

11. Patient is currently participating in any other surgical intervention studies or pain management studies.

12. Patient is known to be pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.).

13. Patient has a known or suspected sensitivity or allergy to one or more of the implant materials.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hillary Overholser

Role: STUDY_DIRECTOR

Zimmer Biomet

Locations

LA BioMed at Harbor-UCLA Medical Center

Torrance, California, United States

Cornerstone Orthopaedics & Sports Medicine, P.C.

Wheat Ridge, Colorado, United States

Hawaii Pacific Health

Honolulu, Hawaii, United States

Henry County Orthopedics and Sports Medicine

New Castle, Indiana, United States

Woods Mill Orthopedics, Ltd

Chesterfield, Missouri, United States

Pinehurst Surgical Clinic

Pinehurst, North Carolina, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

K.CR.I.G.16.33

Identifier Type: -

Identifier Source: org_study_id